AccessGUDID - DEVICE: Circular Sizer (20705036015434)

GUDID

Device Identifier (DI) Information

Brand Name: Circular Sizer
Version or Model: CS31
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CS31
Company Name: ETHICON ENDO-SURGERY, LLC

Primary DI Number: 20705036015434
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044606982 *Terms of Use

Device Description: The Circular Sizer is a non-sterile, stainless steel device sized 31 mm to correspond with the head sizes of ETHICON Circular Staplers (Intraluminal Staplers).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58016	Colorectal sizer	A hand-held manual surgical instrument designed to assess colon and/or rectal lumen diameter to aid the selection of an appropriate size intraluminal stapler (i. e, the stapler head) for bowel anastomosis following transection. It is typically made of high-grade stainless steel and consists of a shaft handle at the proximal end and an oval-shaped head at the distal end that is introduced transanally. The device is typically available in a set of graduated sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0fda8f51-cf0e-4a24-be45-9cc2a510b1b6
Public Version Date: July 24, 2019
Public Version Number: 1
DI Record Publish Date: July 16, 2019